MAUDE Adverse Event Report: BECTON DICKINSON ULTRASAFE X100L PR CLEAR SSL NVS STEIN; ANTISTICK SYRINGE

Catalog Number 47475102

Device Problems Leak/Splash (1354); Material Separation (1562); Difficult or Delayed Activation (2577)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that one ultrasafe x100l pr clear ssl nvs stein has been found experiencing safety mechanism failure during use.The following has been provided by the initial reporter: the plunger disconnected and the auto-retractable needle wasn't engaged.

Manufacturer Narrative

Investigation: unconfirmed, no sample received.Batch record review did not indicate of any incident in relation to the problem statement.Batch was released in accordance to the acceptable criteria.Based on the investigation conclusion, bdm-ps was not able to confirm the symptom perceived by the customer and not correlate this symptom with a potential cause linked to bd process.

Event Description

It has been reported that one ultrasafe x100l pr clear ssl nvs stein has been found experiencing safety mechanism failure during use.The following has been provided by the initial reporter: the plunger disconnected and the auto-retractable needle wasn't engaged.

• Brand Name: ULTRASAFE X100L PR CLEAR SSL NVS STEIN
• Type of Device: ANTISTICK SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; faraday road; dorcan; swindon wiltshire SN3 5 JH; UK SN3 5JH
• MDR Report Key: 9175604
• MDR Text Key: 191317245
• Report Number: 3001741852-2019-00063
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/01/2023
• Device Catalogue Number: 47475102
• Device Lot Number: 1753134
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 09/25/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other